Pelvic implant with suspending system

ABSTRACT

A urethral stabilization system includes a suspending member attached between a stabilizer and support member. The support member is implantable into a patient to support a urethra. A first suspending member is attached between a first end of the support member and a first stabilizer, and a second suspending member is attached between a second end of the support member and a second stabilizer. A first thread member continuously extends between a first end that is attached to the first stabilizer and a second end of the first thread member that is free, and a second thread member continuously extending between a first end that is attached to the second stabilizer and a second end of the second thread member that is free.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/402,978 filed Feb. 23, 2012, which is a continuation of U.S.application Ser. No. 12/072,901 filed Feb. 28, 2008 and now issued asU.S. Pat. No. 8,167,785, which is a continuation-in-part of U.S.application Ser. No. 11/199,061 filed Aug. 8, 2005 and now issued asU.S. Pat. No. 7,789,821, which is a continuation of U.S. Ser. No.10/398,992 filed Apr. 11, 2003 and now issued as U.S. Pat. No.6,960,160, which is the U.S. national stage entry of InternationalPatent Application No. PCT/GB/01/04554 filed Oct. 12, 2001, whichclaimed the priority of GB App. Ser. No. 0025068.8, filed on Oct. 12,2000. Priority to each of the foregoing is claimed.

TECHNICAL FIELD

This invention relates to a system and method for the treatment ofpelvic floor abnormalities, in particular female urinary incontinence.

BACKGROUND OF THE INVENTION

Urinary incontinence is an involuntary release of urine when increasesin abdominal pressure caused by sneezing, coughing, or exercising, forexample, are not uniformly transmitted to the proximal urethra,resulting in urine “leakage.” Moderate urinary incontinence isinconvenient and can be a social and hygienic problem, while severeurinary incontinence can be disabling. Urinary incontinence occurs inwomen and is caused by for example, hypermobility of the bladder neckand proximal urethra (excessive downward and rotational movement of thebladder neck) or intrinsic sphincter deficiency.

Urinary incontinence affects a large number of women and, consequently,various approaches have been developed to treat female urinaryincontinence. Those skilled in the art will be familiar with approachesranging from pelvic floor exercises to surgical techniques such as Burchcolposuspension and Stamey type endoscopic procedures in which thesutures are placed so as to elevate the bladder neck.

One known procedure positions a support, i.e., a sling loosely under theurethra. It is generally understood that this treatment alleviatesurinary incontinence by occluding the mid-urethra (for example at a timeof raised abdominal pressure by coughing or the like).

Problems associated with surgical correction of the failed supportmechanisms include under-correction or over-correction. The surgeon mustdetermine the degree of support necessary to properly elevate andsupport the urethra to properly address the urinary incontinenceproblem. This determination must be made both pre-, intra-, andpost-operatively. Too little elevation causes urinary incontinence toremain, although the degree of incontinence may be reduced. Too muchelevation can result in voiding dysfunction (reduced capacity orinability to void), leading to prolonged catheterization, and the needfor postoperative correction.

The incidence of postoperative urinary retention due to post-operativeobstruction can be high at several weeks after surgery, and a number ofpatients have post-operative urinary retention that persists.Symptomatic detrusor instability represents the bladder's response toincreased outlet resistance caused by an improperly tensioned sling. Theincidence of post-operative irritative symptoms secondary to detrusorinstability can be unacceptably high. Appropriate tensioning of thesuburethral support, i.e., sling minimizes persistent incontinence andvoiding dysfunction. However, appropriate tensioning during surgery isdifficult to assess and frequently is found to be excessive orinsufficient once the patient has assumed normal posture and movementpost-operatively. Methods and devices for immediate and short termpost-operative adjustment of the tension in a suburethral supportmember, i.e., sling for the treatment of urinary incontinence are neededto mitigate the post-operative complications associated withinappropriate tensioning of the sling.

SUMMARY OF THE INVENTION

One of the problems identified and solved by the invention disclosedherein is that appropriate immediate and short-term post-operativetensioning of a suburethral support in a patient can minimize thediscomfort, persistent incontinence and voiding dysfunction that oftencomplicates prior art methods and devices for therapy of pelvic floorabnormalities including urinary incontinence. The invention describedbelow relates to a system and method that permits fine tuning of aurethral support member, i.e., sling tension immediatelypost-operatively and for days up to a week rather than hours after thesling has been implanted in the patient. Accordingly, at least oneobjective according to the invention described herein is to provide asystem and method that mitigates the post-operative complicationsassociated with under-tensioning or over-tensioning a suburethral slingimplanted for the therapy of urinary incontinence or other pelvic floordysfunctional or structural abnormalities.

In one aspect, the invention relates to a supplementary stabilizationsystem for stabilizing the urethra. The stabilization system has a firstelongate thread member and a second elongate thread member, eachelongate thread member comprising an absorbable, flexible materialhaving a length extending from a first end to a second end. In oneembodiment, the second end of each thread member is free. The system forstabilizing the urethra also has a first stabilizer and a secondstabilizer. In one embodiment, the first stabilizer is joined to thefirst end of the first elongate thread member. The second stabilizer isjoined to the first end of the second elongate member thread member.

In one embodiment, the elongate thread members are non-porous, i.e.,having no interstices such as pits, gaps or holes for cellularintegration. The width of each elongate thread member is in the range of0.1 to 2 mm.

The supplementary stabilization system also has a first and secondsuspending member and a support member. The support member has a firstend and a second end. The first suspending member and the secondsuspending member each have a first end and a second end. The first endof each suspending member is joined to one of the first or secondstabilizer. The second end of each suspending member is joined to eitherthe first end or the second end of the support member.

In one embodiment, the support member has a length that is shorter thaneither of the first and second thread member. In one embodiment, thefirst thread member and the second thread member have a width that is inthe range of about 0.8% to 20% of the width of the support member. Eachof the thread first thread member and the second thread member may alsohave a length that is longer than the support member.

In a particular embodiment, the urethral support system has a tensioner.The tensioner includes a mechanism for including and retaining 1 or 2thread members and a mechanism for tightening and loosening the urethralsupport member by mechanically exerting a linear or rotary forcemovement or by manual means.

In another aspect, the invention relates to a method for stabilizing aurethral support member under the urethra to treat urinary incontinence,for example. According to the method, a surgeon introduces a urethralsupport stabilization system including an absorbable first elongatemember and an absorbable second elongate member having a first end and asecond end, and the urethral support member through an incision in thevaginal wall. The first end of the system is introduced to theparaurethral space lateral to the urethra, through the subcutaneoustissue, and through the skin at a first location. The second end of thesystem is introduced in the paraurethral space on the other side of theurethra, through the subcutaneous tissue on that side of the urethra,and through the skin at a second location. In one embodiment the firstand second locations are located on the skin of the abdomen. In anotherembodiment, the first and second locations are located on the perinealskin or the skin of the upper medial leg.

In an alternative method, the order of tissues through which theurethral support system passes is reverse of the order above.

In one embodiment, the urethral support stabilization system furtherincludes a stabilizer connectable to an elongate member. The methodfurther comprises positioning the stabilizer in soft tissue, forexample, in the soft tissue of the retropubic space, the soft tissue ofthe perineal space, or the pre-pubic soft tissue. The stabilizer islocated between an absorbable elongate member and the urethral supportmember. The length of the urethral support stabilization system betweenthe stabilizer and the midpoint of the urethral support member is lessthan the distance between the patient's urethra and the skin at thefirst location. According to the invention, the stabilizer is positionedin pelvic soft tissue without penetrating the rectus sheath, in avaginal to abdominal approach, or the subcutaneous tissue of theperineal skin in a vaginal to perineal approach or in the subcutaneoustissue of the pre-pubic skin in a vaginal to pre-pubic approach.

In one embodiment, the method of the invention further includesproviding a tensioner to the surface of the abdominal perineal, orpre-pubic skin, as the case may be. The tensioner has a first and secondend and is joined to the first and second elongate members,respectively, after the elongate members emerge from the skin. Themethod further includes adjusting the tension on the support member byadjusting the tensioner. At anytime up to ten days after the urethralsupport member is implanted in the patient, tension is applied to thesecond end of the elongate member at the first location. In oneembodiment, the tension is applied manually by the surgeon.Alternatively, tension may be applied to the elongate member andtransmitted to the urethral support member by mechanical means, forexample, by a mechanical rotary or a linear force movement. Themagnitude of the tension is sufficient to permit a remnant of the firstend of the elongate member to retract under the skin after cutting theremnant. The first end of the elongate member is cut while it is undertension wherein the remnant of the first end retracts under the skin.

In one embodiment of the method of the invention, applying tension toone or the other elongate member comprises advancing or withdrawing oneor the other stabilizer in the soft tissues of the patient. As usedherein, withdrawing a stabilizer in the soft tissues of the patientmeans moving the stabilizer back along the path in which the stabilizerwas advanced, i.e., in a reverse direction, without causing significanttrauma to the soft tissue along the path and without applying moreforce, preferably less force, than the force that was required toadvance the stabilizer.

These and other objects, along with advantages and features of thepresent invention herein disclosed, will become apparent throughreference to the following description, the accompanying drawings, andthe claims. Furthermore, it is to be understood that the features of thevarious embodiments described herein are not mutually exclusive and canexist in various combinations and permutations.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing and other objects, features and advantages of the presentinvention disclosed herein, as well as the invention itself, will bemore fully understood from the following description of preferredembodiments and claims, when read together with the accompanyingdrawings. The drawings are not necessarily to scale, emphasis insteadgenerally being placed upon illustrating the principles of theinvention.

FIG. 1 illustrates a plan view of a urethral support system according toan embodiment of the invention;

FIG. 2A illustrates a side view of a first elongate member and a secondelongate member of the urethral support system according to anembodiment of the invention;

FIG. 2B illustrates various embodiments of the cross-sectional shape ofthe first and second elongate members taken at 1B-1B of the urethralsupport system illustrated in FIG. 1;

FIG. 3A illustrates a front view and FIG. 3B illustrates a perspectiveview of a stabilizer of the urethral support system according to anembodiment of the invention;

FIG. 4 illustrates a plan view of a urethral support system including afirst suspending member and a second suspending member according toanother embodiment of the invention;

FIG. 5A illustrates a top view of a urethral support member connected toa stabilizer at each end of the urethral support system according to anembodiment of the invention;

FIG. 5B illustrates a side view of the urethral support member andstabilizer illustrated in FIG. 5A;

FIG. 6A illustrates a top view of a tensioner of the urethral supportsystem according to an embodiment of the invention;

FIG. 6B illustrates a side view of the tensioner illustrated in FIG. 6A;

FIG. 7A illustrates a perspective view of a tensioner of the urethralsupport system according to another embodiment of the invention;

FIG. 7B illustrates an exploded view of the tensioner illustrated inFIG. 7A;

FIGS. 7C-7E illustrate the steps for applying retaining and applyingtension to an elongate member by the tensioner illustrated in FIG. 7A;

FIG. 8A illustrates a sagittal section and FIGS. 8B and 8C illustrate atransverse section of the pelvic area illustrating the steps in a methodfor treating the pelvic floor, for example, for treating urinaryincontinence according to an embodiment of the invention;

FIG. 9A illustrates a sagittal section taken at 9A-9A in FIG. 9B; and

FIG. 9B illustrates a transverse section of the pelvic area illustratingthe steps in a method for treating the pelvic floor, for example, fortreating urinary incontinence, according to another embodiment of theinvention.

DESCRIPTION

FIG. 1 illustrates a urethral support system 20 according to anembodiment of the invention. Referring to FIG. 1, the exemplary urethralsupport system 20 has multiple components including a supplementaryurethral support stabilization system 10 comprising a first elongatemember 22 and a second elongate member 22′. In one embodiment of theinvention, the supplementary urethral support stabilization system 10further includes at least one tensioner (not shown), alternatively twotensioners described below. In another embodiment, the supplementarystabilization system 10 includes a first elongate member 22 and a secondelongate member 22′, and a first stabilizer 24 and a second stabilizer24′. Alternatively, the supplementary urethral support stabilizationsystem 10 includes at least one tensioner, a first and second elongatemember 22, 22′, and a first and second stabilizer 24, 24′. The urethralsupport system 20 further includes a support member 26. In oneembodiment, the urethral support system 20 further includes a firstsuspending member 23 and a second suspending member 23′.

FIGS. 2A and 2B illustrate an embodiment of the supplementary urethralsupport stabilization system 10 of the urethral support system 20including the first elongate member 22 and the second elongate member22′. With reference to FIG. 2A, the exemplary first elongate member 22and the exemplary second elongate member 22′ are substantially identicaland typically thread-like, i.e., not tape or ribbon-like members. Thematerial used to make the elongate member is absorbable, i.e.,biodegradable and does not act as a scaffold to permit ingrowth ofpatient tissues, e.g., fibrous tissue, into the material. Appropriatematerials include absorbable synthetic polymers, lactide, glycolide,caprolactone, co-polymers or combinations of the above, for example. Inone embodiment, the material used to make the elongate member is solid,for example, monofilament without interstices such as pores, pits, orspaces, for example, that would permit cellular integration in thematerial, i.e., not a mesh, braid, knitted, or woven material. Inanother embodiment the material may be braided.

Each of the first elongate member 22 and the second elongate member 22′is longer or as long as the urethral support member 26 (described belowin greater detail). Embodiments of the elongate member made from amonofilament lack the projecting ends of mesh, knitted, woven, orbraided materials and therefore slide in soft tissue more easily forward(advancing) in one direction or backward (withdrawing) in the oppositedirection. In one embodiment, each of the first elongate member 22 andthe second elongate member 22′ includes a first end 30 and a second end32. In one embodiment, the second end 32 is free while the first end 30is joined to another part of the urethral support system 20.

Referring to FIG. 2B, typically, the first elongate member 22 and secondelongate member 22′ of the supplementary urethral support stabilizationsystem 10 have a cross-sectional width in the range of about 0.1 to 2.0millimeters. The cross-sectional shape of the first 22 and secondelongate members 22′ may be round, oval, triangular, or rectangular, forexample. In one embodiment, the thread-like elongate members 22, 22′ aresufficiently flexible to be knotted. The elongate members may be coatedwith an absorbable, i.e., biodegradable lubricious material, forexample, proteins, polysaccharides, hydrophilic polymers, wax, hydrogel,silicone, silicone rubber, PTFE, PBA, ethyl cellulose or the like, toease the sliding of the elongate member in soft tissues. The length ofeach of the first and second elongate members is in the range forexample of about, 6-18 cm, preferably 7-16 cm. The thin, thread-likefeature of the elongate member is advantageous over the prior artbecause the elongate members according to the invention do not permitingrowth of patient tissue and slide in two-directions, i.e., forwardand backward more easily than prior art urethral support sling systemswhich use broad flat tape-like members to encourage ingrowth of patienttissues and can not be moved without causing significant tissue traumaafter operative placement.

FIGS. 3A and 3B illustrate an exemplary stabilizer 24 of thesupplementary urethral support stabilization system 10 of the urethralsupport system 20 according to an embodiment of the invention. Referringto FIG. 3A, the exemplary stabilizer 24 is a planar, elongate,substantially rectangular or oval tab including a radius 51 at thedistal end 52, and is flat at the proximal end 54 opposite to the distalend 52. Alternatively, the stabilizer 24 is substantially cylindrical(not shown) rather than planar or the stabilizer 24 may include a radius51 at the proximal end 54 as well as at the distal end 52. The sides 56of the stabilizer 24 include multiple radii 53, or flat beads, forexample, 2-6 flat beads, more preferably 1-2 flat beads, most preferablyone bead, i.e., radius. Other than the “beads”, all sides of thestabilizer are devoid of projections that may increase the drag orprevent substantially free passage of the stabilizer 24 in soft tissue.The length of the stabilizer 24 is in the range of about 0.8 to 2.0 cm.The width of the stabilizer at its widest point is in the range of about2 to 4 mm, preferably 3 mm. The thickness of the stabilizer is in therange of about 100 to 400 microns, preferably 200 microns.

With continued reference to FIGS. 3A and 3B, in one embodiment of theinvention, the illustrated exemplary stabilizer 24 includes athroughhole 58 at the distal end 52 extending from one surface 61 to theother surface 62 of the stabilizer 24. In one embodiment, thethroughhole 58 operates as an eyelet to which the first end of theelongate member (not shown) may be knotted to connect the stabilizer tothe elongate member. The multiple beads 53 along the sides 56 of thestabilizer 24 permit ratcheting of the stabilizer 24 as it is pulledthrough the fascia of the patient by the surgeon during implantation ofthe urethral support system 20 illustrated in FIG. 1. Ratcheting aidsthe surgeon during the implantation procedure by increasing the “feel”of the system as it is being implanted.

The stabilizer 24 including the beads along the sides, described above,has at least one advantage over prior art stabilizers in that thestabilizer 24 may be reversibly transitioned in tissue, i.e., movementin tissues two-ways: (i) forward along the path of the respectiveelongate member to which the stabilizer 24 is joined, and (ii) backalong the path already taken by the stabilizer 24. Accordingly, thestabilizer 24 permits positional fine-tuning by transitioning thestabilizer 24 forward or backwards, for example, by pulling in eitherdirection during and after delivery of the urethral support system 20 inthe patient's tissues. Moreover, the stabilizers of the supplementarystabilization system 10 aid in holding the urethral support member underthe urethra in a correct position. In addition, the stabilizersaccording to the invention are not readily palpable, or may not bepalpable transvaginally. The stabilizers and/or the supplementarystabilization system, according to the invention, are positioned in thesoft tissue with adequate tensile strength to counter dislodging by, forexample, coughing or straining, or by other instances of increasedintra-abdominal pressure, until suitable integration of the patient'ssoft tissue occurs with the implanted urethral support member.Typically, the timeframe required for integration of the urethralsupport member is about 24 hours to about seven days.

The stabilizer according to the invention differs structurally andfunctionally from prior art devices because prior art devices aretypically pronged, barbed, or have rough surfaces that, once drawn intosoft tissue, cannot be withdrawn along the path already taken by thedevice. In contrast, the stabilizer according to the invention may bewithdrawn along the tissue path already taken with minimal trauma to thesoft tissue and allows forward and backward repositioning of theurethral support member. In particular, the stabilizer according to theinvention permits adjustment to the tension of the urethral supportmember by transmitting the tension to the urethral support memberthrough the stabilizer after the stabilizer is introduced into thepatient's tissues. Because the stabilizer can be moved forward(advanced) and backward (withdrawn), tension transmitted to the urethralsupport member can be reduced as well as increased, a feature notpresent in prior art urethral support systems or methods for treatingurinary incontinence.

Referring again to FIG. 1, the exemplary first stabilizer 24 is joinedto the first end 30 of the first elongate member 22 and the secondstabilizer 24′ is joined to the first end 30 of the second elongatemember 22′ of the supplementary urethral support stabilization system10. The stabilizer may be joined to the elongate member by any meansknown in the art, such as by knotting the elongate member to thestabilizer through the stabilizer throughhole, for example, or bythermal bonding, ultrasonic bonding, application of an adhesive,chemical bonding, or by molding a stabilizer-elongate member combinationsuch that the stabilizer and the elongate member form a single integralpart.

Referring to FIG. 4, in one embodiment, the urethral support system 20further includes a first suspending member 23 and a second suspendingmember 23′ that connect the first stabilizer 24 to one end of theurethral support member 26, and the second stabilizer 24′ to the otherend of the urethral support member, respectively. The suspending members23 may be for example, a strip, such as, for example, a polymer strip.The suspending members may be joined to the support member 26 and/or thestabilizers 24, 24′ by crimping, thermal bonding, chemical bonding,ultrasonic bonding, adhesive, or formed as an integral unit with thestabilizers and or the urethral support member.

Each of the exemplary first suspending member 23 and second suspendingmember 23′ illustrated in FIG. 4 feature an elongated element having alength in the range of about 1 to 3 cm, preferably about 1 to 2 cm. Thewidth of each of the suspending members is typically 11 mm on the endadjacent to the mesh tapering to 2 mm on the end adjacent to thestabilizer.

In another embodiment referring again to FIG. 1, the exemplarysuspending members 23, 23′ form an integral part of the urethral supportmember 26 and taper to the stabilizers 24, 24′, respectively.Alternatively, the urethral support member 26 is joined directly to thestabilizers 24, 24′ without an intervening suspending member (see FIGS.5A-5B).

FIGS. 5A and 5B illustrate a urethral support member 26, such as asling, according to an embodiment of the invention. The exemplaryurethral support member 26 is a flat, ribbon, or tape-like implant.According to one embodiment, the support member 26 is a mesh comprisedof strands. The length of the support member 26 is in the range ofabout, 6 to 20 cm, preferably 7 to 16 cm, more preferably 8 to 14 cmpreferably 12 cm, or 8 cm in length. The width of the urethral supportmember 26 may be in the range of about 6 to 15 mm, preferably 8 to 13mm, more preferably 11 mm in width. The weight of the urethral supportmember 26 is in the range of about 10 to 30 g/m², preferably 15 to 25g/m², more preferably 18 to 20 g/m², most preferably 19 g/m². Exemplaryembodiments of the mesh urethral support member are described in U.S.Ser. No. 10/473,825 and 10/398,992, incorporated by reference herein.The strands of the mesh urethral support member 26 are in the range ofabout 150 to 600 microns in diameter. The strands are arranged such thatthey form a regular network and are spaced apart from each other suchthat for a diamond net arrangement a space of between 2 to 5 mm existsbetween the points where the strands of the mesh interact with eachother. In a hexagonal net arrangement the space is between 2 to 5 mmbetween opposite diagonal points where the strands of the mesh interact.

It is preferable to space the strands as far as part as possible toallow blood to pass through the implant and reduce the mass of theimplant, while providing the mesh with sufficient tensile strength andelasticity to be effective. It can therefore be appreciated thatconsiderable variability in the maximum spacing between the strands canbe achieved depending on the material from which the strands arecomprised and the net pattern in which the strands are arranged.

In one embodiment the strands are arranged in a diamond net pattern,however any pattern which provides suitable tensile strength andelasticity may be used. For example a hexagonal net pattern may be used.

Ideally, in order to reduce the overall mass of the urethral supportmember, the strands should have as narrow a diameter as possible whilestill providing the mesh with suitable tensile strength and elasticity.The strands of the mesh include at least two filaments arranged tointeract such that pores are formed between the filaments. The poresformed between the filaments are around about 50 to 200 microns, such aspacing allowing fibroblast through growth to occur. Fibroblast throughgrowth secures the implant in place within the body. Additionally andimportantly the suitably sized pores allow the implant to act as ascaffold to encourage the deposition of new patient tissue to promoteintegration of the urethral support member into the patient's softtissues.

Suitable materials from which the mesh can be made are sufficientlyinert to avoid foreign body reactions when retained in the human bodyfor long periods of time and have suitably easy handling characteristicsfor placement under the urethra in the desired location in the body. Themesh can be easily sterilized to prevent the introduction of infectionwhen the mesh is implanted in the human body.

For example, the filaments may be formed from any biocompatiblematerial. In one embodiment, the filaments are formed from polyester,wherein each polyester filament is around 0.09 mm in diameter. Suitablematerials of which the filaments may be formed also includepolypropylene.

The filaments of the strands may be knitted together using warp knit toreduce the possibility of fraying of the filaments and strands. The finewarp knit of the filaments provides a urethral support member which isflexible in handling, which can be easily cut into different shapes anddimensions. As the strands are formed using warp knit, the possibilityof fraying of the edge of the urethral support member followingproduction or cutting of the mesh is reduced.

Other methods of reducing fraying of the filaments after cutting orproduction of the mesh include heat treatment, laser treatment or thelike to seal the edges of the mesh.

The mesh may be supplied in any shape or size and cut to the appropriatedimensions as required.

It can be appreciated that cutting of the mesh will produce anunfinished edge. Due to the sparse nature of the strands that form themesh and their narrow diameter, this unfinished edge does not sufferfrom the same problems as edges of meshes of the prior art.

In other words the edge produced is not rough and jagged such that itincreases the likelihood of extrusion of the edge of the mesh in situ orthe chance of infection.

An advantage of the mesh of the present invention is that it allowssubstantially less foreign material to be left into the body thanconventional meshes for pelvic region repair.

However, to improve handling the mesh described above may be treatedusing an absorbable coating. The absorbable coating includes, forexample, a layer of absorbable material having a thickness greater thanthat of the strands of the mesh. For example, the thickness of the layerof absorbable material may be around 1 to 2 mm. The strands of the meshmay be entirely embedded in the absorbable coating such that the outersurface of the mesh is covered entirely of the absorbable coatingencasing the entire urethral support member.

Accordingly, in this embodiment, urethral support member has no gaps orholes on its surface to reduce the likelihood of bacteria becominglodged on the strands of the mesh before implantation of the mesh.Furthermore, the absorbable coating makes the mesh more substantial andless flexible such that it is more easily handled by a surgeon.

In an alternative embodiment, the absorbable coating includes a layer ofabsorbable material applied to one face of the mesh, such that the meshhas a first face on which the absorbable material has been applied and asecond face on which the absorbable material has not been applied suchthat the first and second faces and each have different characteristics.

It can also be envisaged that the surgical implant is provided withimproved surgical handling qualities by a range of other methods. Suchmethods include the releasable attachment of the mesh to a backingstrip.

The backing strip may be formed from plastics material and is adhered tothe surgical implant using releasable adhesive.

In a similar fashion to the absorbable coating the backing strip causesthe mesh to be more substantial and less flexible such that it is moreeasily handled by a surgeon. Following the suitable placement of themesh the backing strip can be removed from the mesh, the mesh beingretained in the body and the backing material being removed by thesurgeon. Application of the backing strip to the mesh means the meshbenefits from reduced mass but that the mesh and backing strip togethergive characteristics required for surgical handling.

In a further embodiment, the filaments of the mesh may be comprised frombicomponent microfibres or composite polymers. These technologiesprovide the implant with dual phase technology.

The bicomponent microfibres comprise a core and surface material. Thesurface material may be resorbed by host tissues in a matter of hours,while the core material remains in the body for a longer period toenable tissue ingrowth.

Suitable bicomponent microfibres include a polypropylene non-absorableportion and a polylactic acid absorbable portion, for example.

The surface material is present during the surgical procedure when themesh is being inserted and positioned in the soft tissues of thepatient, and provides the mesh with characteristics desirable forsurgical handling. Following implantation in the patient's body,typically a few hours, the surface material is absorbed by the bodyleaving only the core material of the filaments in the body. The corematerial of the filament has reduced foreign mass in comparison tomeshes of the prior art or the mesh when it also includes the surfacematerial.

The mesh of the urethral support member may be formed from compositepolymers. As described for the bicomponent microfibres, compositepolymers provide the urethral support implants with dual phasetechnology. A first face of the mesh has particular characteristics suchas flexibility and elasticity, while a second face of the mesh providesthe mesh with characteristics which improved the surgical handling ofthe mesh such as strength and robustness. The mesh results in anunfinished edge. This mesh is not as likely to cause the same problemsas the rough and jagged edges of the of prior art mesh, due to the fewerstrands, smaller diameter filaments and treatment of the mesh withabsorbable coating which protects the tissue from the mesh duringimplantation when damage is most likely to occur.

In a further embodiment, the mesh has perimeter strands. Typically, themesh is circular or the like in shape and thus the perimeter strand canbe generally referred to as a circumferential strand. One strand runsaround the circumference of the oval shape of the mesh. In anotherembodiment, several circumferential strands may be present, eachcircumferential strand may extend over one side of the oval mesh, i.e.around half the circumference of the mesh. In another embodiment, thecircumferential strands arc arranged concentrically and each extendsaround the mesh at a different radial location.

An outer circumferential strand extending around the perimeter of themesh, and further circumferential strands are arranged inwardly of theouter circumferential strand forming a perimeter spaced by a distance.The distance between adjacent circumferential members, can vary and inthis example is 20 mm.

Transverse strands extend from the centre of the oval mesh to points onthe perimeter of the mesh. In this example, four transverse strands areprovided across the diameter of the mesh, dividing the mesh into eightangularly equal portions.

The mesh of this embodiment may be formed from materials as previouslydescribed. Depending on the material chosen the mesh may be woven,knitted or extruded as one piece, or individual or groups of strands canbe extruded separately and joined to one another.

In another embodiment, meshes may have angled sides. A mesh according tothis embodiment has a similar structure to that described above.However, the mesh has a perimeter member having angled sides. Further itmay have transverse members arranged only to extend towards theperimeter of the mesh, rather than all being across the diameter of themesh. This provides a more uniform structure. More specifically, themesh has a transverse member extending along its axis of symmetry, atransverse member bisecting the axis of symmetry, and four furthertransverse members extending from the axis of symmetry to the perimeterof the mesh.

In addition to the pores provided by the combination of filaments whichform the strands, pores can be provided by rings of polypropylenepositioned at the intersection of the circumferential and transversemembers.

Alternatively the pores may be formed by the spacing of the transversemembers, such that pores of a size 50 to 200 microns suitable forenabling tissue ingrowth between the transverse members.

With continued reference to FIGS. 5A and 5B, the urethral support member26 has a first end 40 and a second end 42. In one embodiment, the lengthof the urethral support member 26 is shorter than the length of eitherof the first elongate member 22 and second elongate member 22′. Forexample, the length of the urethral support member 26 is about 5-100%,preferably about 5-60%, more preferably, 5-30%, most preferably 5-20%,of the length of either the first elongate member 22 or the secondelongate member 22′. The width of each elongate member may be in therange of about 0.1-30%, 0.8-20%, 1-20%, or 5-10% of the width of theurethral support member, for example.

Referring still to FIGS. 5A and 5B, in one embodiment, the first end 40of the urethral support member 26 is joined to the first stabilizer 24,and the second end 42 of the urethral support member 26 is joined to thesecond stabilizer 24′. The end of the support member may be attached toeither the first or second stabilizer by ultrasonic welding, thermalbonding, chemical bonding, an adhesive, or by a mechanical means suchas, a fastener, a hook and eye, suture, and post and slot, for example.The attachment of the ends of the support member to the first or secondstabilizer may be permanent or reversibly attached.

Referring to FIGS. 6A and 6B, in one embodiment according to theinvention, the urethral support system 20 further comprises a tensioner50. Any of the tensioners described herein may be reversibly attached tothe patient's skin by, for example, an adhesive.

The exemplary tensioner 50 illustrated in FIGS. 6A and 6B typically issubstantially flat to lie close to the skin thereby avoiding beinginadvertently dislodged. The shape may be any suitable shape such asround, rectangular or oval as illustrated in FIG. 6A. The length of thetensioner is in the range of about 1 to 6 cm, preferably, 3 to 6 cm, 1to 3 cm, or 1-4 cm. The width is in the range of about 1 to 4 cm, andthe depth is in the range of about 0.5-3 cm.

At each end of the tensioner 50 illustrated in FIGS. 6A and 6B, one hole52, 52′, more preferably two holes at each end of the tensioner 50,extend from the top surface 56 through the body of the tensioner 50 tothe bottom surface 57 of the tensioner 50. The diameter of each hole 52,52′ is sufficient to easily accommodate the second end 32 of theelongate member 22, 22′ of the supplementary stabilization system 10 ofthe urethral support system 20. In one embodiment, the diameter of eachhole 52, 52′ is in the range of about 5 mm or less, preferably 3 mm. Aplurality of smaller diameter holes 54, 54′, for example, linearlyarranged at each end of the tensioner 50, extend from the top surface56, through the body of the tensioner to the bottom surface 57 on bothends of the tensioner 50. The diameter of holes 54, 54′ is smaller thanholes 52, 52′ to allow for pinching or clamping of the second end of theelongate member 22, 22′ when the elongate member is pulled from itsemergence through the larger holes 52, 52′ at the top surface 56 of thetensioner 50 over to the smaller holes 54, 54′ thereby pinching,cleating or clamping the second end 32 of the elongate member 22 to thetensioner 50.

As an alternative to the embodiment of the tensioner 50 described above,an adhesive may be used alone or in concert with the holes for attachingthe second end 32 of the elongate member 22 to the tensioner 50. In yetanother embodiment, the tensioner 50 may include only one hole 52.

Referring to FIGS. 7A-7C, in an alternate embodiment, the tensionercomprises a rotary device to provide mechanical advantage by rotaryforce movement for adjusting the tension on the suburethral supportmember. The illustrative rotary force tensioner 60 illustrated in anassembled configuration in FIG. 7A and in an exploded format in FIG. 7B,includes a wheel 62 and a wheel ratchet 63. The wheel 62 rotatably locksinto the wheel ratchet 63 by, for example, a clip 64, preferably twoclips 64, located opposite to one another on the rim 65 of the wheelratchet 63. At least one ridge 66 perpendicular to the long axis of thewheel ratchet 63 is positioned on the clip 64 and projects towards thecenter of the wheel ratchet 63.

Referring now to FIGS. 7C-E, the wheel 62 includes at least one gate 67located on the perimeter of the wheel 62. The gate 67 is a partiallydetached wedge-like portion of the outer rim 70 of the wheel 62. Thesecond end 32 of the elongate member 22 passes between the gate 67 andthe inner rim 68 of the wheel 62. As the wheel 62 is manually rotatablyratcheted on the wheel ratchet 63 by rotating the knob 71 indicated byarrow 69 in FIG. 7D, the gate 67 is compressed by the ridge 66 againstthe inner rim 68 and the elongate member 22 is locked within thetensioner 50 between the gate 67 and the inner rim 68 of the wheel 62 asillustrated in FIG. 7E.

In one aspect, the invention relates to a kit for treatment of urinaryincontinence. In one embodiment, the kit includes a urethral supportstabilization system. The urethral support stabilization system includesa first and second elongate member, a first and second stabilizer andoptionally a urethral support member, for example a mesh sling. In oneembodiment, each of the elongate members comprise an absorbable,non-porous material, without interstices that would permit cellularingrowth. In another embodiment, each of the stabilizers comprise asubstantially planar member with multiple radii, i.e., beads asdescribed above projecting from the edge of the planar surface. Thestabilizer may further feature a throughhole at one end. In anotherembodiment, the kit of the invention may further include a tensionerincluding a hole for pinching the end of an elongate member or anadhesive for adhering to an elongate member.

In another aspect, the invention relates to a method for providingurethral support in a patient, such as, for the therapy of femaleurinary incontinence, and/or uterovaginal prolapse, for example.Referring to FIGS. 8A to 8C, in one embodiment of the method of theinvention, a surgeon takes a vaginal to abdominal skin approach byincising the vaginal wall 108 to provide a site for the introduction ofthe urethral support system 20, described above, to the para-urethralarea, i.e., adjacent to the urethra. The supplementary stabilizationsystem 10 including the first elongate member 22 led by the second 32 orfree end, is passed through the vaginal incision, around one side of theurethra 114, through the soft tissue of the retro-pubic space 112,behind the pubic bone 102, through the rectus sheath 104, subcutaneoustissue 118, and abdominal skin 106 to emerge on the surface of theabdominal skin 106 at a first abdominal location. According to oneembodiment, the first end 30 of the first elongate member 22 of thesupplementary stabilization system 10 is pre-attached to the firststabilizer 24. Alternatively, the first end 30 of the first elongatemember 22 of the supplementary stabilization system 10 is attached tothe first stabilizer 24 during the surgical procedure. In yet anotherembodiment, the elongate member and stabilizer are detachable.

In one embodiment, the first stabilizer 24 is positioned in the softtissue of the retropubic space 112, while the elongate member 22 emergesfrom the abdominal skin 106. The first stabilizer 24 is positioned inthe retropubic space, i.e., it does not pass through any of theintervening tissues i.e., rectus sheath, subcutaneous tissue and skin,between the retropubic space and the skin surface.

The first end 40 of the urethral support member 26 is pre-attached tothe first stabilizer 24. Alternatively, the first end 40 of the urethralsupport member 26 is attachable and detachable to the first stabilizer24 during the surgical procedure. A portion of the urethral supportmember 26, for example, a first portion extending from approximately themid-point to one end of the urethral support member, is positioned onthe side of the urethra 114 through which the first elongate member 22passed.

This procedure is repeated with the second elongate member 22′, secondstabilizer 24′, and the support member 26 on the other side of theurethra 114. As with the first stabilizer 24, the second stabilizer 24′is positioned in the retropubic space but at a location different thanthe first stabilizer 24. The second stabilizer 24′ does not pass throughany of the intervening tissues i.e., rectus sheath, subcutaneous tissueand skin, between the retropubic space and the skin surface. Followingintroduction of the second elongate member 22′ and the second stabilizer24′, the remaining urethral support member 26 is positioned under theurethra 114 with one end of the support member on one side of theurethra 114 and the other end of the support member on the other side ofthe urethra 114.

In one embodiment, the first stabilizer 24 and the second stabilizer 24′cannot extend into the intervening tissues between the retropubic spaceand the skin surface largely because the length of the urethral supportmember 26 from its midpoint under the urethra to one end of the urethralsupport member and the length of the suspending member, if one is used,that is positioned on one side of the urethral support member to whichthe stabilizer is connected, is shorter than the distance between theurethra and the rectus sheath.

Referring to FIG. 8B, following the emergence of the second elongatemember 22′ at a second abdominal location, the position of the urethralsupport member 26 under the urethra is adjusted and stabilized byapplying tension via the supplementary stabilization system 10 to one,the other, or both of the first 22 elongate member and second elongatemember 22′. Tension may be applied manually, i.e., by hand withoutmechanical aids or by a system that includes mechanical aids such as bymechanically applying rotary or linear force movement, and, further, maymeasure and or regulate the applied tension. The tension is transmittedfrom the elongate members to the first and second stabilizers 24, 24′.For example, by applying tension such as by pulling the first elongatemember 22 at its second end 32, the first stabilizer 24 advances throughthe soft tissue while the second stabilizer 24′ is withdrawn through thesoft tissue along the path already taken by the second stabilizer 24′.

Referring to FIG. 8C, in one embodiment of the method of the invention,the supplementary stabilization system 10 further includes the tensioner50, such as the tensioner 50 described above with respect to FIGS. 6Aand 6B. The exemplary tensioner 50 is joined to the free ends 32, 32′ ofthe first and second elongate members 22, 22′, respectively, emergingthrough, for example, the abdominal skin 106. The tension of theurethral support member 26 is adjusted by applying tension to the secondend 32, 32′, respectively, of the first and second elongate members 22,22′. The urethral support member 26 may be moved from side-to-sidebecause the stabilizer 24, 24′, illustrated in FIGS. 3A and 3B, may bepulled back and forth in the soft tissues in contrast to prior artdevices which have prongs, hooks, barbs or other obtrusive projectionsto prevent the device from being withdrawn from the soft tissue alongthe path of entry.

In another embodiment, the surgeon takes a vaginal to perineal approach.The perineum corresponds to the outlet of the pelvis inferior to thepelvic diaphragm (levator ani and coccygeus). The boundaries of theperineum are provided by the pubic arch and the arcuate ligament of thepubis, the tip of the coccyx and on either side of the inferior rami ofthe pubis and ischium, and the sacrotuberous ligament. A line joiningthe anterior parts of the ischial tuberosities divides the perineum intotwo portions, the posterior anal triangle portion and the smalleranterior urogenital triangle.

In the vaginal to perineal approach, referring now to FIGS. 9A and 9B, asurgeon incises the vaginal wall 108 to provide a site for theintroduction of the urethral support system 20, described above, to thepara-urethral area. The supplementary stabilization system 10 includingthe first elongate member 22 led by the second 32 or free end, is passedthrough the vaginal incision, around one side of the urethra 114,through the soft tissues of the perineal space 110 including theperineal muscles and towards and behind the inferior pubic ramus, butnot through the obturator foramen, through the subcutaneous tissueunderlying the skin of the perineum 150, emerging on the surface of theperineal skin 150 at a first perineal location.

The first stabilizer 24 is positioned in the soft tissues of theperineal space 110 while the elongate member 22 emerges from theperineal skin 150. The first stabilizer 24 is positioned in the softtissue of the perineal space 110, i.e., the first stabilizer 24 does notpass through the skin.

The first end 40 of the support member 26 is pre-attached to the firststabilizer 24. Alternatively, the first end 40 of the support member 26is attachable and detachable to the first stabilizer 24 during thesurgical procedure. The support member 26 is positioned on the side ofthe urethra 114 through which the first elongate member 22 passed.

Referring to FIG. 9B, this procedure is repeated with the secondelongate member 22′, second stabilizer 24′ and the support member 26 onthe other side of the urethra 114. As with the first stabilizer 24, thesecond stabilizer 24′ is positioned in the perineal space 110 at alocation different than the first stabilizer 24. The second stabilizer24′ does not pass through the skin. Neither the first stabilizer 24 northe second stabilizer 24′ are positioned at a location above theendopelvic fascia. Moreover, the urethral support system used for avaginal to perineal approach does not extend through the abdominal wallor the obturator foramen. Following introduction of the second elongatemember 22′ and the second stabilizer 24′, the urethral support member 26is positioned under the urethra 114 with one end of the urethral supportmember 26 on one side of the urethra 114 and the other end of theurethral support member 26 on the other side of the urethra 114.

In one embodiment, the first stabilizer 24 and the second stabilizer 24′cannot extend into the intervening tissue between the perineal space andthe skin surface because the length of the urethral support member fromits midpoint on one side of the urethra to one end of then urethralsupport member and the length of the suspending member, if one is used,is less than the distance between the urethra and the perineal skin.Typically, for the vaginal to perineal approach the length of theurethral support member from its midpoint on one side of the urethra andthe suspending member on the same side of the urethra, if one is used,is in the range of about 3 to 6 cm, preferably 4 cm.

Following the emergence of the second elongate member 22′ at a secondperineal skin location, the position of the urethral support member 26under the urethra is adjusted and stabilized by applying tension to oneor the other of the first 22 and second elongate member 22′, or both.Tension may be applied manually, i.e., by hand without mechanical aidsor by a system that includes mechanical aids such as by mechanicallyapplying rotary or linear force movement, and further, may measure andor regulate the applied tension. As discussed above, the tension istransmitted from the elongate members to the first and secondstabilizers 24, 24′. For example, applying tension such as by pullingthe second end 32 of the first elongate member 22, the first stabilizer24 advances through the soft tissue while the second stabilizer 24′ iswithdrawn through the soft tissue along the path already taken by thesecond stabilizer 24′.

A first tensioner 50 is joined to the free end 32 of the first elongatemember 22 of the supplementary stabilization system 10 that emergesthrough the perineal skin at a first location. A second tensioner 50 isjoined to the free end 32′ of the second elongate member 22′ of thesupplementary stabilization system 10 emerging through the perineal skinat a second location. The tension of the urethral support member 26 isadjusted by applying tension to the first elongate member 22 and thesecond elongate member 22′.

In one embodiment, the skin locations may be on the medial aspect of thethighs.

In another embodiment of the method of the invention, the stabilizers24, 24′ are positioned in the pre-pubic soft tissue and the ends 32 ofthe first and second elongate members 22, 22′ emerge through thepre-pubic skin.

Alternatively, the route through tissues can be reversed, for example,for an abdominal to vaginal approach, the urethral support system wouldpass through tissues in the following order, abdominal skin at a firstlocation, subcutaneous tissue, rectus sheath, retropubic space,suburethral space, and finally, through the vaginal incision. Thesesteps would be repeated on the other side starting at a second abdominalskin location.

For a perineal to vaginal approach, the urethral system would passthrough tissues in the following order, perineal skin at a firstlocation, subcutaneous perineal tissue, perineal muscles, suburethralspace and finally through a vaginal incision. The steps would berepeated on the other side starting at a second perineal skin location.

Regardless of the surgical approach, according to the invention,intra-operative and post operative adjustment of the urethral supportmember, for example by adjusting the tension applied to the urethralsupport member, may be performed for up to one week, preferably 72 hoursafter surgery. For example, in one embodiment of the method, thetensioner 50 is left in place for 1 to 7 days following implantation ofthe urethral support member 26. The ends 32 of the first and secondelongate members 22, 22′ emerging through the abdominal wall, perinealskin, or pre-pubic skin as the case may be, are transected after firstapplying tension to the free ends 32, 32′ to pull a portion of theelongate members 22, 22′ adjacent to the free end from below the skin,through the skin, to the skin surface. The portion of the elongatemember that was below the skin is cut so that the remnant of theelongate member after cutting that was under tension retracts back underthe skin. The same procedure is repeated with the elongate memberemerging at the second abdominal, perineal, or pre-pubic location, asthe case may be. The one or more tensioners are removed from thepatient.

In a particular embodiment of the method of the invention, the vaginalincision is closed, e.g., by suturing followed by adjustment of thetension of the urethral support member by transmitting tension from theelongate members through the stabilizers to the urethral support member.

What is claimed is:
 1. A urethral stabilization system comprising: asupport member adapted to be implanted into a patient to support aurethra; a first suspending member attached between a first end of thesupport member and a first stabilizer and a second suspending memberattached between a second end of the support member and a secondstabilizer; a first thread member continuously extending between a firstend that is attached to the first stabilizer and a second end of thefirst thread member that is free and a second thread member continuouslyextending between a first end that is attached to the second stabilizerand a second end of the second thread member that is free; wherein thefirst and second stabilizers are adapted to be implanted into tissue ofthe patient and each stabilizer is movable to adjust tension applied tothe support member.